The invention relates to the chemical-pharmaceutical industry and specifically to mix for identification test in the process of quality control of the medicine “Glycine tablets for sublingual applying 0.1 g”, methods of its preparation and identity evaluation during quality control of the specified medicine.
The medicine “Glycine tablets for sublingual applying 0.1 g” (hereinafter referred to as Glycine) activates inhibitory processes in central nervous system, exhibits properties of α1 adrenoceptor blocking agent and has stressprotecive, antistress, nootropic andxieuroprotecrive effect.
For production of the medicine “Glycine tablets for sublingual applying 0.1 g” there are used microcapsules in the form of non-agglomerated crystals of amino-acetic acid filmed by water-soluble methyl-cellulose, MC-100 and magnesium stearate. Long-term experience of Glycine utilization has demonstrated that the optimum efficacy is achieved by a tablet with the decomposition period varying from 10 to 20 minutes, crushing resistance ranging from 10 to 30 N, containing 0.101 g of microcapsuled glycine and 0.001 g of magnesium stearate.
Dissolution of the medicine with the specified composition and physico-chemical properties is attended by buildup of special structures which provide maximum therapeutic effect. In its turn character and degree of structuring by using particular methods render it possible to carry out quantitative assessment of tablet qualitative composition in aqueous medium. (EA B1 No. 7615, IPC 8 GO1N 21/17, 2006). In the process of manufacturing of the medicine Glycine, taking into consideration formulation and low content of adjuncts most difficulties occur with adherence to the interval of decomposition period since amino-acetic acid is easily water-soluble. It is easy to overcome these difficulties if pelletizing mass formulation is adhered to. Glycine plays part of a special ingredient structure in the form of microcapsules (non-agglomerated crystals of amino-acetic acid, filmed by water-soluble methyl-cellulose MC-100) in this formulation whereas a tablet itself as a ‘substance’ is composition structure, obtained by compression which save to the utmost microcapsules integrity.
Controllable decomposition period can be attained by use of microcapsuled glycine and strict adherence to the particular pelletizing mass formulation. (RU C1 No. 22171673, IPC 7 A61K 9/50, 2001). Preparation of the medicine “Glycine tablets for sublingual applying 0.1 g” of high efficiency requires strict adherence to qualitative and quantitative formulation, use of the particular ingredient structure (microcapsuled Glycine), included in palletizing mass and particular structure of final substance—medicine, that can be achieved upon condition that high production, standards are observed. Taking into account some difficulties in production of the drug “Glycine tablets for sublingual applying 0.1 g” (as related to decomposition period), lack of simple and accessible methods of identification of adjunct substances in the State quality standard of drugs leads to massive violations of the medicine formulation concerning adjunct substances by unscrupulous manufacturers for the purpose of frivolous cheapening. Such violations mostly result in self-tapering action and in some cases loss of its pharmacological effects. In this context it is worthy of note that 140 years after amino-acetic acid had been invented pharmacological effects were obtained only with the particular medicine structure and method of its utilization.
There is known mix for identity test of the medicine- “Glycine tablets for sublingual applying 0.1 g”, involving purified water and porphyrized tablets in a ratio 100:1 with light transmission coefficient of 4 ml mix and layer thickness of 10 mm and wave length 700±2 nm in comparison with purified water ranging from 50% to 70%. (pharmacopeia FC 42-0159-05; EA B1 No. 7615, 1PC 8 G01N 21/17, 2006).
It has been shown practically” that the base mix specified makes us evaluate violations of the formulation identity for water-soluble and non-soluble substances. Adjuncts abundance and manufacturers sophistication referring to formulation violation require extra methods of evaluation for adulteration detecting.